EMEA-000804-PIP01-09-M02 - paediatric investigation plan

atazanavir (as sulfate)

Key facts

• Invented name:
  • Reyataz
  • Reyataz
• Active substance:
  atazanavir (as sulfate)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0098/2014
• PIP number:
  EMEA-000804-PIP01-09-M02
• Pharmaceutical form(s):
  • Capsule
  • Hard oral powder
• Condition(s) / indication(s):
  Treatment of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/04/2014
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-000804-PIP01-09-M02
• Compliance opinion date:
  13/02/2015
• Compliance outcome:
  Positive

Decision

P/0098/2014: EMA decision of 10 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for atazanavir (sulphate) (Reyataz), (EMEA-000804-PIP01-09-M02)

Adopted Reference Number: EMA/169115/2014